We are a full-service CDMO for small molecules, offering our customers innovative solutions to their bespoke projects, from the early clinical phase through to the commercial stage. With more than 40 years of CDMO expertise, we provide pharmaceutical companies with reliable, high-quality chemical compounds by developing cost-efficient manufacturing processes in full compliance with environmental, health and safety, and cGMP international standards.

Process Development

We make ourselves fully available to our customers because everything starts at development. Our state-of-the-art R&D centers are where we make everything possible.

Our team of highly qualified chemists create and validate synthesis routes used in world-class products within the pharmaceutical industry.

We implement innovative approaches to find cost-efficient solutions that enable complex molecules to reach the market quickly and in a manner that does not compromise on quality.

We assist our customers technologically and scientifically throughout the development process while offering the knowledge and capacity to support them throughout the product lifecycle.

We offer a wide range of services:

  • Technology Transfer Process Development
  • Cost oriented route scouting
  • New Technology development
  • Fluorination
  • Production Support
  • Analytical methods: development, validation, cross-validation
  • Process optimization
  • Scaling up
  • Troubleshooting

API Life Cycle Management

We take care of all the stages of the development process.

Scaling up is a crucial step of the process. Our experts possess a wealth of knowledge in designing precise scale-up processes to move up to full production.

  • From clinical phase I to commercial
  • Scale up from gram to tons
    • Kilolab
    • Pilot plant
  • Multipurpose Manufacturing Plant
  • cGMP and non-GMP Facilities
  • Continuous process improvement
  • Project Management

Broad Technology Portfolio

Our multipurpose concept plants offer a broad technology portfolio, including fluorination, for which AGC Pharma Chemicals is considered a global leader.

 

We continue to invest in our infrastructure and increase capacity to provide more solutions and technologies.

 

We are also getting ready for digital transformation, Industry 4.0.

One of our primary initiatives is shifting to a paperless manufacturing solution, integrating the Electronic Batch Record into the Distributed Control System (DCS). This transformation will enable our customers to connect to the batch processes via smart devices.

Some of our technologies:

  • Fluorination
  • Bromination
  • Hydrogenation
  • Cryogenic reaction
  • HAPI
  • Micronization
  • Continuous Flow
Please contact us for more information.

Raw Material Sourcing and Supply Chain

Our aim is to take care of the entire supply chain from raw materials to final API.

 

The procurement department in Spain, together with our offices in Shanghai (China), Gurgaon (India) and Tokyo (Japan), provide support through a worldwide supplier network to assure quality and competitive costing materials aligned with the project timeline defined by you.

 

Through our non-GMP facilities in Japan, we can offer backward integration in your supply chain.

Our Supply Chain department ensures the procurement of materials and the production plan, considers capacity and resources available in order to fulfil the demand, to guarantee the proper flow of materials from procurement to sale.

Our raw material management is optimized to provide agility and efficiency in our production. We are fully aligned with established service level targets and compliant with GMP regulations in our warehouse and GDP in worldwide distribution and export trade requirements for worldwide distribution.